Ireland
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Recruiting Not applicable

NOn-inVAsive Blood Pressure Monitoring in Intracranial Aneurysm Embolization

NCT07246148 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2026-04-09

Condition(s) studied

Cerebral AneurysmsIntracranial AneurysmsCoil EmbolizationHemodynamic InstabilityNoninvasive Cardiac Monitoring

Investigational drug(s) / intervention(s)

Non-invasive continuous blood pressure monitoringInvasive arterial blood pressure monitoring

Non-invasive continuous blood pressure monitoring: Continuous arterial blood pressure monitoring using a finger-cuff technology (e.g., ClearSight system). Applied in the experimental NVBP group.

Invasive arterial blood pressure monitoring: Standard radial arterial catheterization for continuous invasive blood pressure monitoring. Applied in the IABP control group.

Study summary

The goal of this clinical trial is to evaluate whether non-invasive continuous blood pressure monitoring (NVBP) using the ClearSight system can safely serve as an alternative to radial arterial catheterization for invasive arterial blood pressure monitoring (IABP) in patients undergoing coil embolization for unruptured intracranial aneurysms.

The main questions it aims to answer are:

* Does NVBP monitoring detect intraoperative hypotension and hypertension events with similar reliability compared to IABP?
* Does NVBP monitoring reduce the need for invasive arterial catheterization without compromising patient safety or clinical outcomes?

Researchers will compare patients assigned to NVBP monitoring with those receiving conventional IABP monitoring.

Participants will:

* Be randomly assigned to NVBP monitoring or standard IABP monitoring during coil embolization.
* Receive continuous monitoring of cerebral oxygenation with near-infrared spectroscopy (rSO₂).
* Undergo standard anesthesia induction, maintenance, and postoperative intensive care protocols.
* Have their intraoperative hemodynamic events, vasopressor use, and postoperative outcomes recorded up to 30 days after the procedure.

Eligibility

Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Adult patients (≥19 and ≤80 years old) scheduled for elective coil embolization of unruptured intracranial aneurysms under general anesthesia. * American Society of Anesthesiologists (ASA) physical status classification I-III. Exclusion Criteria: * Patients who do not provide informed consent. * Patients unable to understand or follow study instructions due to physical or mental limitations. * Patients in whom radial arterial catheterization is not feasible (e.g., peripheral vascular disease, skin disorders at the insertion site, absence of radial/ulnar artery, or orthopedic conditions of the upper extremity). * Patients with peripheral vascular circulatory disorders. * Patients with morbid obesity (BMI ≥ 40 kg/m²) \[Eley et al., 2021\]. * Patients who are hemodynamically unstable preoperatively or expected to be unstable during the perioperative period.

Primary outcome measure(s)

  • Intra-procedural hemodynamic instability events (hypotension or hypertension events) — During the procedure (Day 0)
    Incidence of hemodynamic instability during coil embolization. Hypotension is defined as mean arterial pressure (MAP) \< 65 mmHg sustained for ≥ 1 minute. Hypertension is defined as systolic arterial pressure \> 120 mmHg sustained for ≥ 1 minute.

Trial sites (1)

FacilityCityRegionStatus
Korea University Anam Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07246148 on ClinicalTrials.gov ↗ ← All trials in South Korea